Comparing proton and photon therapy for IDH-mutated gliomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of proton therapy compared to traditional photon therapy in patients with IDH-mutated grade II and III diffuse gliomas. It aims to determine if proton therapy can achieve similar survival rates while potentially improving quality of life and reducing rehabilitation needs. Patients aged 18 to 65 with a confirmed diagnosis will be randomized to receive either treatment, and their outcomes will be assessed over a two-year period. The study will also include neuropsychological testing to evaluate cognitive abilities post-treatment.

Why it matters

Who can join: the full rules

1. Patients must be 18 to 65 years old on the day of consent.
2. IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.
3. Indication for radiotherapy.
4. WHO/ECOG performance status 0-2.
5. Ability to undergo MRI.
6. No significant contrast enhancing tumour (more than 1 or 2 punctate contrast enhancing foci) at the time of randomization. In recurrence patients, no contrast enhancement is allowed unless a new biopsy confirms the diagnosis of IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3.
7. Ability and willingness to travel to a proton therapy centre if randomized to the proton therapy arm.
8. Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception during radiotherapy, chemotherapy and 1 year after completion of chemotherapy. Pregnancy is not an ineligibility criterium if radiotherapy is indicated and cannot be postponed
9. Ability to understand the information about the study and included treatment.
10. Signed informed consent.
11. Ability to speak and understand Norwegian or Swedish language.

Exclusion Criteria:

1. Prior treatment (except surgery) for diffuse glioma
2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years
3. Known CDKN2A/B homozygous deletion
4. Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up
5. Body weight \> 150 kg

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Petter Brandal, MD PhD — Head of Neurooncology
• Study coordinator: Petter Brandal, MD PhD
• Email: petter.brandal@ous-hf.no
• Phone: +47 22934000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.